MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Device evaluation: the failure was confirmed by a company representative during the testing. The device was evaluated and it was determined that the membrane was wrapped incorrectly by the operator during the tight wrapping operation. This is evident by the folds present in the membrane after it was pulled from retainer, see. When comparing the improperly folded membrane in, to a properly folded membrane also tested in this protocol it is clear that the membrane was wrapped incorrectly. An additional comparison can also be made between the improperly folded membrane and the non-acceptable sample pictures from the linear 7. 5fr. Iab tight wrap packaging & inspection procedure. (b)(4).

Event Description

It was reported by a datascope representative that an iab was found to have a failure for pull from retainer force after it had been released for distribution, during testing for a protocol. The value was 5. 04lb which exceeds the <5lb requirement.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7859433
• MDR Text Key: 119811232
• Report Number: 2248146-2018-00537
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/02/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000039567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage